Largest Clinical Study Focusing on GAINSWave® for Erectile Optimization Approved to Begin Enrolling Patients
SAN RAMON, Calif., Aug. 13, 2019 /PRNewswire/ -- The Landmark SWEET Clinical Study (Shock Wave Erectile Enhancement Trial), run by Board-Certified urologist and specialist in male sexual medicine, Dr. Judson Brandeis has received approval from the Integreview Institutional Review Board (IRB). The SWEET study aims to enroll 3,000 participants at over 40 SWEET Study sites, which will make it the largest observational study on Shock Wave Therapy for Erectile Dysfunction (ED) ever performed.
GAINSWave® Shock Wave Therapy is a noninvasive treatment for vasculogenic ED, which occurs when blood flow to the penis is compromised. The primary goal of the SWEET Study is to evaluate the outcomes of shockwave therapy across the diverse range of treatment protocols used by providers throughout North America. Other targets of interest include identifying optimal treatment plans, identifying factors that predict superior outcomes, and quantifying long term efficacy.
The initial study on Shock Wave Therapy for ED was published in 2010. Since that time, over 40 small-scale studies have been conducted, which established Shock Wave Therapy as effective and safe. "IRB approval is the first major step in the SWEET Study that allows us to begin recruiting participants," mentioned Dr. Brandeis.
The SWEET study has 40 top tier GAINSWave providers contributing their patient outcomes data. These providers will be applying their unique treatment protocols to patients at their clinics, with details on each treatment and erectile dysfunction psychometrics recorded by the research team. "We'll do an interim analysis part-way through the study to give providers and participants early data, I can't wait," shares Dr. Scott Lu, Dr. Brandeis' Clinical Research Director.
"A large-scale Clinical Registry is long overdue to quantify how well GAINSWave works. Those of us in clinical medicine have directly observed the benefits to our patients. It is time to understand who benefits the most, fine-tune the protocols based on data and learn how long the effects last. I appreciate that GAINSWave assisted in recruiting their high-volume providers to participate in this Landmark study," shared Dr. Brandeis.
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GAINSWave is a breakthrough, noninvasive medical treatment that uses low-intensity shockwave therapy to enhance sexual performance and to treat Erectile Dysfunction (ED) symptoms. For more information on the study, Dr. Lu and Dr. Brandeis can be contacted directly at Research@BrandeisMD.com and Scott@BrandeisMD.com.
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